Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

The Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) have announced the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement (RFA-FD-26-007). This initiative, with an activity code of U01, aims to strengthen scientific, collaborative, and operational foundations to modernize regulatory oversight in a rapidly evolving public health landscape. PRISM seeks to advance public health by promoting timely access to safe, effective, and high-quality products. Key goals include advancing the use of real-world data, evidence, and AI; strengthening patient access to investigational therapies; enhancing transparency and public trust in regulatory science; supporting gold-standard science-based approaches in food safety and nutrition; and advancing competition and domestic innovation. The FDA intends to commit $1,300,000 for fiscal year 2026, with the possibility of one award providing up to five years of support, contingent on funding and performance. The Reagan-Udall Foundation for the Food and Drug Administration is the sole eligible applicant for this single-source funding opportunity. Applications are due by April 30, 2026.